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NCT02020889 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT02020889 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 136 participants.
The verdict
NCT02020889, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
Interventions
- DRUG Placebo
- BIOLOGICAL Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-02-05 |
| Est. Completion | 2016-09-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02020889
The ClinicalTrials.gov registry entry for NCT02020889 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02020889 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02020889 about?
NCT02020889 is a clinical study titled "A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis". The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granul...
What is the current status of trial NCT02020889?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2014-02-05. Estimated completion is 2016-09-05.
What interventions are being tested in trial NCT02020889?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02020889?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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